ibrexafungerp

Inhibits glucan synthase, which then inhibits formation of 1,3-β-D-glucan, a necessary component of the fungal cell wall.

Therapeutic effects:

Resolution of signs/symptoms of vulvovaginal candidiasis without need for additional antifungal therapy or topical drug therapy.
Reduction in recurrence of vulvovaginal candidiasis.

Spectrum:

Exerts fungicidal effects against the following fungal pathogen:
- Candida albicans.

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following oral administration.

Distribution: Widely distributed to extravascular tissues.

Protein Binding: >99%.

Metabolism/Excretion: Primarily metabolized in liver via the CYP3A4 isoenzyme to an inactive metabolite. Primarily excreted in feces (51% as unchanged drug) with 1% excreted in urine.

Half-Life: 20 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	4–6 hr	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
OB: Pregnancy.

Use Cautiously in:

Severe hepatic impairment;
Rep: Women of reproductive potential;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness have not been established in premenarchal children.

Adv. Reactions/Side Effects ⬆ ⬇

GI: abdominal pain, diarrhea, nausea, vomiting

Neuro: dizziness

Interactions ⬆ ⬇

Drug-drug:

Strong CYP3A inhibitors, including itraconazole or ketoconazole, may ↑ levels and risk of toxicity; ↓ ibrexafungerp dosage.
Strong CYP3A inducers, including bosentan, carbamazepine, efavirenz, etravirinephenobarbital, phenytoin, and rifampin, may ↓ levels and effectiveness; avoid concurrent use.

Drug-Natural Products:

St. John's wort may ↓ levels and effectiveness; avoid concurrent use.

Route/Dosage ⬆ ⬇

Treatment of Vulvovaginal Candidiasis

PO (Adults and Children Postmenarchal patients): 300 mg every 12 hr for 1 day (total dosage = 600 mg). Concurrent use of strong CYP3A inhibitor: 150 mg every 12 hr for 1 day (total dosage = 300 mg).

Reduction in Recurrence of Vulvovaginal Candidiasis

PO (Adults and Children Postmenarchal patients): 300 mg every 12 hr for 1 day; repeat monthly for a total of 6 mo. Concurrent use of strong CYP3A inhibitor: 150 mg every 12 hr for 1 day; repeat monthly for a total of 6 mo.

Availability ⬆ ⬇

Assessment ⬆ ⬇

Assess for signs and symptoms of vulvovaginal candidiasis (pruritus, vaginal soreness, vulvar irritation, dyspareunia, external dysuria, vaginal discharge, rash) and monitor for improvement.
Monitor for signs and symptoms of urinary tract infection (dysuria, urinary frequency, hematuria, foul urine odor, pelvic pain, flank pain, fever, chills). Report to health care professional and treat as indicated.

Lab Test Considerations:

Verify negative pregnancy test before starting therapy; reassess pregnancy status prior to each dose when used monthly.
- Consider obtaining vaginal culture for Candida to determine if use of ibrexafungerp is appropriate.

Implementation ⬆ ⬇

PO: Administer every 12 hr for 1 day with or without food. Give on same day of month for 6 mo when used monthly.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of ibrexafungerp to patient. Explain need for continued medical follow-up to assess effectiveness of medication. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications. St. John's wort should be avoided during treatment.
Rep: May cause fetal harm. Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Advise women of reproductive potential to use effective contraception throughout the 6-mo treatment period and for 4 days after the last dose. Report any suspected fetal exposure to SCYNEXIS, Inc. at 1-888-982-SCYX (1-888-982-7299) or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch .

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Pronunciation ⬇

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